MOUNTAIN VIEW, Calif. and BARCELONA, Spain, Feb. 21, 2013 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) and Grupo Ferrer Internacional, S.A., today announced that the European Commission has granted marketing authorization for ADASUVE ( Staccato loxapine). In the European Union (EU), ADASUVE, 4.5 mg and 9.1 mg inhalation powder loxapine, pre-dispensed, is authorized for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder.
The ADASUVE marketing authorization requires that patients receive regular treatment immediately after control of acute agitation symptoms, and that ADASUVE is administered only in a hospital setting under the supervision of a healthcare professional. Short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects (bronchospasm).
"The centralized EU marketing authorization for ADASUVE delivered by the European Commission is an important milestone for Alexza," said Thomas B. King, President and CEO of Alexza. "ADASUVE is the first authorized non-injectable therapy for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. We believe that the ability to deliver this medicinal product rapidly and non-invasively will be important for patient care."
King continued, "Our EU partner, Grupo Ferrer, is preparing for ADASUVE's launch and we are very pleased to support their pre-launch efforts. We are planning to launch ADASUVE in the third quarter, in both the US and the EU.""Our focus with the initial EU launch of ADASUVE will be Germany and Austria in 2013, with a planned launch into the rest of the EU countries in 2014," said Jordi Ramentol, CEO of Grupo Ferrer. "At the same time, we are compiling the registration dossiers for the non-EU countries in our licensed territory, and we plan to complete all of these submissions before the end of 2013." Ramentol continued, "ADASUVE is central to our near-term corporate strategy. We are very proud to bring this new technology to healthcare professionals for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder."